Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention, coronary artery disease, stent optimization, post-dilatation
Brief summary
To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment. Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear. For this reason, the OPTIMIZE PCI was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.
Detailed description
The Netherlands Heart Registration (NHR) is an independent organization in which Dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including PCI. Data provided to the NHR are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. Multiple audits are conducted annually by the NHR for data validation and verification. A waiver for informed consent for analysis with the data of the NHR data registry is obtained.
Interventions
BEHAVIORALLiberal post-dilatation strategy during PCI
A liberal post-dilatation strategy for stent optimization during PCI will be implemented in multiple centers in the Netherlands. This include an increase of post-dilatation use of at least 20% per operator, or a percentage of post-dilatation of at least 85%. Operators will be asked to enforce a very low threshold for post-dilatation in general, with a mandatory HPNC post-dilatation for the following indications: * In case of any calcification * Delta of ≥ 0.5mm between the distal and proximal reference diameter of the treated coronary segment * Stent length \>24 mm * Signs of incomplete stentframe-deployment on angiography or StentBoost * In case of CTO * In case of bifurcation PCI (Left main and non-left main) * Proximal Optimisation Technique (POT) with NC balloon * Final Kissing Balloon dilatation (FKB) with preferentially first sequential high-pressure inflations and final low pressure kiss both with NC balloons
Sponsors
Medtronic
Cathreine BV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients \>18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project
Exclusion criteria
\- If a patient has multiple PCIs within 365 days, only the first procedure is included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality | 30 day | The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 30 days, 1 year | all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database. |
| Target vessel revascularization | 30 days and 1 year | Target vessel revascularization, defined as a revascularization by percutaneous coronary intervention or coronary artery bypass grafting in the same vessel(s) that had been treated at the index procedure, excluding staged procedures. |
| Myocardial infarction | 30 day | Myocardial infarction, defined as an increase and/or decrease in one or more cardiac biomarkers by at least one value above the 99th percentile of the upper limit where at least one of the following symptoms is present: 1) symptoms appropriate to ischemia, 2) new significant ST-segment or T-wave abnormalities or bundle branch block, 3) development of pathological Q-waves on the electrocardiogram (ECG), 4) imaging demonstrated new loss of viable myocardial tissue or new wall motion abnormalities, 5) identification of intracoronary thrombus on angiography or autopsy. |
Countries
Netherlands
Contacts
Primary ContactK Teeuwen, MD, PhD
Backup ContactK.A.J. Beek, MD
Outcome results
None listed